Cleared Traditional

K873485 - EDSLAB OCCLUSION BALLOON CATHETER

K873485 is the FDA 510(k) clearance for EDSLAB OCCLUSION BALLOON CATHETER by American Edwards Laboratories. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K873485 · American Edwards Laboratories · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1987
Decision
94d
Days
Class 2
Risk

K873485 is an FDA 510(k) clearance for the EDSLAB (R) OCCLUSION BALLOON CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by American Edwards Laboratories (Santa Ana, US). The FDA issued a Cleared decision on December 3, 1987 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all American Edwards Laboratories devices

Submission Details

510(k) Number K873485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1987
Decision Date December 03, 1987
Days to Decision 94 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 125d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 577
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K873485.
ACS HI-TORQUE CORONARY GUIDING CATHETER W/SOFT TIP
K874874 · Advanced Cardiovascular Systems, Inc. · Feb 1988
TRACKER-25 INFUSION CATHETER
K874751 · Target Therapeutics · Feb 1988
ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLE
K875269 · Advanced Cardiovascular Systems, Inc. · Feb 1988
VASCULAR ACCESS PORT/CATH CAT. #VP-XXX VASPORT SER
K873035 · Gish Biomedical, Inc. · Sep 1987
SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX
K863791 · Gish Biomedical, Inc. · Jun 1987
J-CATH, GISH MODEL NO. JVAC-XXXX
K863790 · Gish Biomedical, Inc. · Jun 1987